Constriction device including reinforced suture holes

ABSTRACT

A constriction device that constricts body tissue is configured to be safely sutured to constricted body tissue. The device includes a generally cylindrical elastic sleeve including opposed opened ends and having a wall of substantially uniform thickness that receives body tissue therein to be constricted. The sleeve includes a plurality of suture holes to receive a suture to maintain the sleeve the tissue constricted by the sleeve. The sleeve includes a suture hole reinforcement structure, as for example an increased wall thickness, about each suture hole to permit the device to be sutured to constricted body tissue without damaging the device.

BACKGROUND OF THE INVENTION

[0001] The present invention is generally directed to a constrictiondevice that constricts body tissue. The present invention is moreparticularly directed to a constriction device that includes reinforcedsuture holes to permit a suture to maintain the constriction device frombeing dislodged from the constricted body tissue while protecting theintegrity of the constriction device.

[0002] Constriction devices have been contemplated for constricting bodytissue. Such devices have been considered for use, for example, intissue resection procedures and in treating pulmonary disease.

[0003] Chronic Obstructive Pulmonary Disease (COPD) has become a majorcause of morbidity and mortality in the United States over the lastthree decades. COPD is characterized by the presence of airflowobstruction due to chronic bronchitis or emphysema. The airflowobstruction in COPD is due largely to structural abnormalities in thesmaller airways. Important causes are inflammation, fibrosis, gobletcell metaplasia, and smooth muscle hypertrophy in terminal bronchioles.

[0004] The incidence, prevalence, and health-related costs of COPD areon the rise. Mortality due to COPD is also on the rise. In 1991 COPD wasthe fourth leading cause of death in the United States and had increased33% since 1979.

[0005] COPD affects the patient's whole life. It has three mainsymptoms: cough; breathlessness; and wheeze. At first, breathlessnessmay be noticed when running for a bus, digging in the garden, or walkingup hill. Later, it may be noticed when simply walking in the kitchen.Over time, it may occur with less and less effort until it is presentall of the time.

[0006] COPD is a progressive disease and currently has no cure. Currenttreatments for COPD include the prevention of further respiratorydamage, pharmacotherapy, and surgery. Each is discussed below.

[0007] The prevention of further respiratory damage entails the adoptionof a healthy lifestyle. Smoking cessation is believed to be the singlemost important therapeutic intervention. However, regular exercise andweight control are also important. Patients whose symptoms restricttheir daily activities or who otherwise have an impaired quality of lifemay require a pulmonary rehabilitation program including ventilatorymuscle training and breathing retraining. Long-term oxygen therapy mayalso become necessary.

[0008] Pharmacotherapy may include bronchodilator therapy to open up theairways as much as possible or inhaled β-agonists. For those patientswho respond poorly to the foregoing or who have persistent symptoms,Ipratropium bromide may be indicated. Further, courses of steroids, suchas corticosteroids, may be required. Lastly, antibiotics may be requiredto prevent infections and influenza and pheumococcal vaccines may beroutinely administered. Unfortunately, there is no evidence that early,regular use of pharmacotherapy will alter the progression of COPD.

[0009] Lung transplantation is also an option. Today, COPD is the mostcommon diagnosis for which lung transplantation is considered.Unfortunately, this consideration is given for only those with advancedCOPD. Given the limited availability of donor organs, lung transplant isfar from being available to all patients.

[0010] About 40 years ago, it was first postulated that the tetheringforce that tends to keep the intrathoracic airways open was lost inemphysema and that by surgically removing the most affected parts of thelungs, the force could be partially restored. Although the surgery wasdeemed promising, the procedure was abandoned.

[0011] The lung volume reduction surgery (LVRS) was later revived. Inthe early 1990's, hundreds of patients underwent the procedure. However,the procedure has fallen out of favor due to the fact that Medicarestopped remitting for LVRS. Unfortunately, data is relatively scarce andmany factors conspire to make what data exists difficult to interpret.The procedure is currently under review in a controlled clinical trial.However, what data does exist tends to indicate that patients benefitedfrom the procedure in terms of an increase in forced expiratory volume,a decrease in total lung capacity, and a significant improvement in lungfunction, dyspnea, and quality of life.

[0012] Improvements in pulmonary function after LVRS have beenattributed to at least four possible mechanisms. These include enhancedelastic recoil, correction of ventilation/perfusion mismatch, improvedefficiency of respiratory musculature, and improved right ventricularfilling.

[0013] The improvements in pulmonary function resulting from LVRS cannotbe ignored. However, the surgery is very invasive and fraught withcomplications. Among the complications is the potential for lung airleaks. Lung tissue is very thin, and fragile hence difficult to suturetogether. After a lung portion is sectioned and removed, the remaininglung is most often restructured with suture staples. In about thirtypercent (30%) of the cases, the difficulty with suturing lung tissueresults in air leaks. Treatment for such air leaks depends upon theirseverity and often, in the most serious cases, requires further openchest surgery.

[0014] Air leaks in lungs can be caused by other causes. With increasingage, a patient may develop a weakened section of lung which may thenrupture due to an extreme pressure differential, such as may result fromsimply a hard sneeze. AIDS patients can suffer from air leaks in theirlungs. Air leaks in lungs can further be caused by a puncture from abroken rib or a stab wound.

[0015] The invention disclosed and claimed in copending U.S. applicationSer. No. 09/534,244, incorporated herein by reference, provides animproved therapy for treating COPD and air leaks in lungs. The therapyincludes a constriction device which, when deployed on a lung,suppresses air leaks in the lung tissue without requiring any suturingof the effected lung tissue. Still further, by constricting a largeenough portion of a lung with the device, lung volume reduction with theconcomitant improved pulmonary function may be obtained without the needfor any suturing of lung tissue at all.

[0016] The lung constriction device includes a jacket or sheath offlexible material configured to cover at least a portion of a lung. Thejacket has a pair of opened ends to permit the lung portion to be drawninto the jacket. The jacket is dimensioned to constrict the lung portionafter the lung portion is drawn therein. The lung constriction device ispreferably formed of expandable, such as elastic, material for receivingthe lung tissue while the device is in an expanded or enlargedcondition, and then contractible about the lung portion upon release ofthe expanded condition for constricting the lung tissue.

[0017] An important aspect of the device and method disclosed in U.S.application Ser. No. 09/534,244 is the ability to sever the constrictingdevice intermediate its ends. This allows a significant portion of theconstricted lung tissue to be removed altogether while permitting aportion of the constricting device to remain in the body for continuedsuppression of air leaks and maintenance of the remaining lung tissueintegrity.

[0018] Devices and methods similar to those disclosed in U.S.application Ser. No. 09/534,244 may be employed to advantage in otherand different procedures such as in general resection procedures and forbody tissue other than lung tissue. Resection procedures are commonlyperformed for such body tissue as, for example, atrial appendage tissue,ovarian tissue, gall bladder tissue, pancreatic tissue, appendix tissueand spleen tissue. Resection procedures may be required to treat cancer,organ damage, or organ disease, for example.

[0019] U.S. application Ser. No. 09/534,244 also discloses and claimsvarious methods and apparatus for deploying the constricting device onbody tissue such as lung tissue. One apparatus and method contemplatesmechanically expanding the device in a transverse dimension whilephysically pulling the tissue to be constricted into the device.

[0020] Another method contemplates mounting the device over a vacuumchamber and pulling the tissue into the vacuum chamber by engaging thetissue with an opened end of the chamber and then drawing a vacuum inthe chamber. This draws the tissue into the chamber. Then, the chamberis withdrawn from the device, leaving the tissue constricted in thedevice.

[0021] A further method contemplates inserting the device into a vacuumchamber and sealing the opened end of the chamber to the device. Theopened end of the chamber and the tissue are then brought into sealingengagement. A vacuum is next pulled in the chamber and the device topull the tissue into the device and chamber. Once the tissue is withinthe device, the chamber is removed from over the device leaving thetissue constricted in the device.

[0022] Although various methods and apparatus have been conceived foreffectively deploying constriction devices on body tissue, theconstriction devices, over time, may become dislodged due to the natureof the soft tissue on which they are deployed. More specifically, softbody tissue has a tendency to expand at the proximal end of the devicecausing longitudinal slippage of the device on the body tissue. This mayeventually lead to the device slipping totally free from the tissue.

[0023] To meet the needs for fixation, U.S. application Ser. No.09/902,821, filed Jul. 10, 2001, and incorporated herein by reference,discloses and claims a constriction device having positive fixationstructure for maintaining the constriction device deployed on the bodytissue.

[0024] One disclosed device includes a plurality of fixation elements onthe inner surface of the sleeve that grasp the body tissue upon releaseof the sleeve from the expanded condition. More particularly, thefixation elements are adjacent to one of the opposed openings andarranged in a side-by-side relation to grasp the body tissue betweenadjacent fixation elements when the sleeve is released from the expandedcondition. The fixation elements may be integral to thelongitudinal-side wall or adhered to the inner surface of the sleeve.Still further, the inner surfaces of the fixation elements may haveroughened surfaces to further assist in grasping the constricted bodytissue.

[0025] While the fixation structures disclosed and claimed in theaforementioned U.S. application Ser. No. 09/902,821 are believed to besufficient alone for maintaining the constriction device on theconstricted body tissue, it is contemplated herein that other forms offixation may be further employed alone or in combination with the abovedescribed fixation structures for maintaining the constriction device onthe constricted body tissue. One additional form of fixation widelypracticed in the medical field is suturing.

[0026] While suturing would appear to be an option, simply suturing theconstriction device to the constricted body tissue would pose a numberof problems. Such problems would arise because the material from whichthe constriction device is formed is relatively thin elastic material.The suturing of such material could easily cause tearing of the deviceby the suture. Moreover, the very act of puncturing the device materialwith a suture needle could readily cause tearing of the device material.Hence, there is a need in the art for a constriction device configuredto permit the suturing of the device to constricted body tissue which isstructured to protect against the tearing of the device material byeither the suture or a suture needle. The present invention addressesthat need. the device material by either the suture or a suture needle.The present invention addresses that need.

SUMMARY OF THE INVENTION

[0027] The present invention provides a constriction device thatconstricts body tissue, and which is configured to be sutured toconstricted body tissue while protecting the integrity of the device.The device includes an elongated sleeve including at least one openedend and being formed from elastic material to receive, when in anexpanded condition, body tissue to be constricted and to constrict thebody tissue when released from the expanded condition. The devicefurther includes at least one suture hole that receives a suture tomaintain the sleeve on the body tissue and a reinforcement structureabout the at least one suture hole.

[0028] The reinforcement structure may be an increased thickness of thesleeve about the at least one suture hole. The sleeve may include aplurality of suture holes and the increased thickness may be about eachof the suture holes.

[0029] Preferably, the suture holes are distributed about the sleevenear to the at least one opened end.

[0030] The increased thickness of the sleeve may be formed as a bandcircumscribing the sleeve with the sutures holes extending through theband. The increased thickness may further have a tapered cross-sectionfor guiding a suture needle into the suture holes. The increasedthickness may extend from the inner surface of the sleeve or from theouter surface of the sleeve.

[0031] The reinforcement structure may alternatively be a layer ofelastic material having a higher tear strength than the elastic materialof the sleeve and which is disposed about each of the suture holes. Thelayer of elastic material may be a continuous band about the sleeve.

[0032] In accordance with further aspects, the present invention furtherprovides a constriction device that constricts body tissue. The deviceincludes a generally cylindrical elastic sleeve including opposed openedends and having a wall of substantially uniform thickness that receivesbody tissue therein to constrict the body tissue and at least one suturehole to receive a suture to maintain the sleeve on tissue constricted bythe sleeve. The sleeve wall has an increased thickness, greater than thesubstantially uniform thickness, about the at least one suture hole.

[0033] The present invention still further provides a constrictiondevice that constricts body tissue, and including sleeve means formed ofelastic material including at least one opened end for constricting bodytissue received therein, suture hole means for receiving a suture tomaintain the sleeve means on the body tissue, and suture holereinforcing means about the suture hole means for reinforcing the suturehole means.

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The features of the present invention which are believed to benovel are set forth with particularity in the appended claims. Theinvention, together with further objects and advantages thereof, maybest be understood by making reference to the following descriptiontaken in conjunction with the accompanying drawings, in the severalfigures of which like reference numerals identify identical elements,and wherein:

[0035]FIG. 1 is a simplified sectional view of a thorax illustrating arespiratory system having a constricting device embodying the presentinvention deployed on a portion of a lung to effect lung volumereduction;

[0036]FIG. 2 is a sectional view similar to FIG. 1 but illustrating therespiratory system after the constricted lung portion has beenresectioned;

[0037]FIG. 3 is a perspective view illustrating a constricting deviceembodying the present invention;

[0038]FIG. 4 is a cross-sectional view of a suture hole of the device ofFIG. 3 and a suture hole reinforcement structure embodying the presentinvention;

[0039]FIG. 5 is a perspective view of another constriction deviceembodying the present invention;

[0040]FIG. 6 is a cross-sectional view of a suture hole of the device ofFIG. 5 and a suture hole reinforcement structure configured inaccordance with another embodiment of the present invention;

[0041]FIG. 7 is a perspective view of another constriction deviceembodying the present invention; and

[0042]FIG. 8 is a cross-sectional view of a suture hole of theconstriction device of FIG. 7 and illustrating its reinforcing structurein accordance with a still further embodiment of the present invention.

DETAILED DESCRIPTION

[0043] Referring now to FIG. 1, it is a sectional view of a respiratorysystem 20. The respiratory system 20 resides within the thorax 22 whichoccupies a space defined by the chest wall 24 and the diaphragm 26.

[0044] The respiratory system 20 includes the trachea 28, the leftmainstem bronchus 30, the right mainstem bronchus 32, and the bronchialbranches 34, 36, 38, 40, and 42. The respiratory system 20 furtherincludes left lung lobes 52 and 54 and right lung lobes 56, 58, and 60.Each bronchial branch communicates with a respective different portionof a lung lobe, either the entire lung lobe or a portion thereof.

[0045] A healthy respiratory system has an arched or inwardly arcuatediaphragm 26. As the individual inhales, the diaphragm 26 straightens toincrease the volume of the thorax 22. This causes a negative pressurewithin the thorax, The negative pressure within the thorax in turncauses the lung lobes to fill with air to an inflated condition. Whenthe individual exhales, the diaphragm returns to its original archedcondition to decrease the volume of the thorax. The decreased volume ofthe thorax causes a positive pressure within the thorax which in turncauses exhalation of the lung lobes.

[0046]FIG. 1 also shows a constriction device 70 embodying the presentinvention deployed on lobe 58. The device 70 is configured as a sleeveor sheath formed of a sheet of elastic biocompatible material. Thematerial may be formed from silicone rubber, polyurethane, expandedpolytetraflouroethylene, polyester and polyurethane, or nylon andpolyurethane, for example. The sleeve is preferably opened at both endsand may be generally cylindrical in configuration.

[0047] The sleeve may be applied to the lung lobe while in an expandedcondition. This may be accomplished by expanding the sleeve with avacuum and then pulling the lung portion into the sleeve with thevacuum. When the lung portion is within the sleeve, the expansion of thedevice is released. With the expansion released, the sleeve is permittedto contract or collapse about the lung portion to constrict the lungportion.

[0048] The device 70 may be employed, for example, to suppress airleakages in lungs. It may also find use to advantage in constricting alung portion suffering from COPD to simulate or achieve lung volumereduction. All of the beneficial effects of lung volume reductionsurgery may be realized and, most importantly, without requiringsuturing of lung tissue. In accordance with the present invention, theconstriction device 70 is fixed on the constricted lung tissue by asuture 71. To that end, the device 70 preferably includes at least onesuture hole, and more preferably at least two suture holes. The sutureholes are reinforced as will be described subsequently so that when thedevice is sutured to the lung tissue, neither the suture needle nor thesuture tears or adversely affects the integrity of the device 70.

[0049]FIG. 2 shows the respiratory system 20 after the constricted lungportion has been resectioned. The device 70 is preferably formed ofseverable material, such as, any of the materials previously described.This enables the device 70 to be severed or cut intermediate its endswith a suitable bladed instrument to resection the lung lobe 58. Theportion of the device 70 remaining on the lobe 58 continues to constrictthe lung tissue therein to form an effective seal from leakage. Thesuture 71 continues to maintain the device 70 on the remainingconstricted tissue. Hence, lung volume reduction is rendered anavailable treatment while negating the need of conventional lungsectioning and avoiding the potentially severe complications whichaccompany such a procedure.

[0050]FIG. 3 illustrates a constriction device 80 embodying the presentinvention. The device 80 is a generally cylindrical sleeve 81 having alongitudinal dimension 82 and a transverse dimension 84. As previouslymentioned, the device 80 is preferably formed of an elastic materialpermitting the device to expand in the longitudinal dimension and moreimportantly in the transverse dimension. The device 80 has opposedopened ends 86 and 88. The device may further include at one end, forexample, end 88 an integral rim 90.

[0051] In accordance with the present invention, the device 80 furtherincludes a plurality of suture holes 92. The suture holes 92 arepreferably distributed about the device closely adjacent the opened end88. As may best be seen in FIG. 4, about each suture hole 92 is a suturehole reinforcement structure 94. In accordance with this embodiment, thesuture hole reinforcement structure 94 of each suture hole 92 is anincreased thickness or thickened portion 96 in the sleeve wall 98 fromthe generally uniform thinner wall thickness 99. The increased thicknessextends outwardly from the outer surface 100 of the sleeve 81 to definea ring shaped structure about each suture hole 92. As will further benoted in FIG. 4, the reinforcement structure 94 of each suture hole 92defines a tapered surface 102. The tapered surface serves to help guidea suture needle through its corresponding suture hole.

[0052] The suture holes 92 may be preformed so as to initially extendthrough the sleeve. Alternatively, the suture holes may be defined bythe reinforcement structures 94 and more particularly the taperedsurfaces 102 without being preformed. This leaves the suture holes to bepunched through during the suturing process. However, by virtue of thesuture hole reinforcement structures, such punching through can beaccomplished safely without damage to the device 80.

[0053]FIG. 5 illustrates another constriction device 110 embodying thepresent invention. Again, the device 110 is a generally cylindricalsleeve 111 having a longitudinal dimension 112 and a transversedimension 110. As previously mentioned, the device 110 is preferablyformed of an elastic material permitting the device to expand in thelongitudinal dimension and more importantly in the transverse dimension.The device 110 has opposed opened ends 116 and 118 and an integral rim120 and end 118.

[0054] Like the device 8 of FIG. 3, the device 110 includes a pluralityof suture holes 122 distributed about the sleeve 111 closely adjacentthe opened end 118. About each suture hole 122 is a suture holereinforcement structure 124. As best seen in FIG. 6, each reinforcementstructure 124 is an increased thickness or thickened portion 126 in thesleeve wall 128 from the generally uniform wall thickness 129. Here,however, the increased thickness extends inwardly from the inner surface130 of the sleeve 111 to define a ring shaped structure about eachsuture hole 122. As will further be noted in FIG. 6, the reinforcementstructure 124 of each suture hole 122 defines a tapered surface 132. Thetapered surface serves to help guide a suture needle through itscorresponding suture hole.

[0055] Again the suture holes may be preformed so as to initially extendthrough the sleeve. Alternatively, the suture holes may be defined bythe reinforcement structures without being preformed. While this leavesthe suture holes to be punched through during the suturing process,however, such punching through can be accomplished safely without damageto the device by virtue of the suture hole reinforcement structures.

[0056]FIGS. 7 and 8 illustrate another constriction device 140 embodyingthe present invention. The device 140 again is a generally cylindricalsleeve 141 having opposed opened ends 142 and 144. Adjacent the openedend 144 and extending about the sleeve is a continuous band 146. Theband 146 may be a thickened portion of the sleeve from its substantiallyuniform thickness 147 or preferably is an additional layer of elasticmaterial but having a higher tear resistance than the material formingthe sleeve 141 that is bonded to the sleeve 141. The band includes aplurality of apertures 148 defining suture holes for the sleeve 141. Theapertures 148 include tapered surfaces 150 to guide a suture needlethrough the apertures and the sleeve. The suture holes are thusreinforced by the band 146 against tearing or the like by the suture orsuture needle. Here, however, the wall thickness of the sleeve 141 mustbe punched through by the suture needle passing through the suture holes148.

[0057] While the invention has been described by means of specificembodiments and applications thereof, it is understood that numerousmodifications and variations could be made thereto by those skilled inthe art without departing from the spirit and scope of the invention. Itis therefore to be understood that within the scope of the claims, theinvention may be practiced otherwise than as specifically describedherein.

What is claimed is:
 1. A constriction device that constricts bodytissue, the device comprising: an elongated sleeve including at leastone opened end and being formed from elastic material to receive, whenin an expanded condition, body tissue to be constricted and to constrictthe body tissue when released from the expanded condition; at least onesuture hole that receives a suture to maintain the sleeve on the bodytissue; and a reinforcement structure about the at least one suturehole.
 2. The device of claim 1 wherein the reinforcement structure is anincreased thickness of the sleeve about the at least one suture hole. 3.The device of claim 2 wherein the sleeve includes a plurality of sutureholes and wherein the reinforcement structure is an increased thicknessabout each of the suture holes.
 4. The device of claim 3 wherein thesuture holes are distributed about the sleeve.
 5. The device of claim 3wherein the suture holes are distributed about the sleeve near to the atleast one opened end.
 6. The device of claim 3 wherein the increasedthickness of the sleeve forms a band circumscribing the sleeve andwherein the suture holes extend through the band.
 7. The device of claim6 wherein the band is near to the at least one opened end.
 8. The deviceof claim 1 wherein the reinforcement structure includes a taperedcross-section that guides a suture needle into the at least one suturehole.
 9. The device of claim 2 wherein the sleeve has an inner surfaceand wherein the increased thickness extends from the inner surface ofthe sleeve.
 10. The device of claim 2 wherein the sleeve has an outersurface and wherein the increased thickness extends from the outersurface.
 11. The device of claim 1 wherein the reinforcement structureis a layer of elastic material having a higher tear strength than theelastic material of the sleeve.
 12. The device of claim 1 including aplurality of suture holes extending through the sleeve and wherein thereinforcement structure is a layer of elastic material having a highertear strength than the elastic material of the sleeve and about each ofthe suture holes.
 13. The device of claim 12 wherein the layer ofelastic material forms a continuous band about the sleeve.
 14. Aconstriction device that constricts body tissue, the device comprising:a generally cylindrical elastic sleeve including opposed opened ends andhaving a wall of substantially uniform thickness that receives bodytissue therein to constrict the body tissue; and at least one suturehole that receives a suture to maintain the sleeve on tissue constrictedby the sleeve, the sleeve wall having an increased thickness, greaterthan the substantially uniform thickness, about the at least one suturehole.
 15. The device of claim 14 wherein the sleeve includes a pluralityof suture holes and wherein the sleeve wall has an increased thickness,greater than the substantially uniform thickness, about each of thesuture holes.
 16. The device of claim 15 wherein the suture holes aredistributed about the sleeve.
 17. The device of claim 15 wherein thesuture holes are distributed about the sleeve near one of the opposedopened ends.
 18. The device of claim 14 wherein the increased thicknessof the sleeve forms a band circumscribing the sleeve and wherein thesuture holes extend through the band.
 19. The device of claim 18 whereinthe band is near to one of the opposed opened ends.
 20. The device ofclaim 14 wherein the at least one suture hole includes a taperedcross-section that guides a suture needle into the at least one suturehole.
 21. The device of claim 14 wherein the sleeve has an inner surfaceand wherein the increased thickness extends from the inner surface ofthe sleeve.
 22. The device of claim 14 wherein the sleeve has an outersurface and wherein the increased thickness extends from the outersurface.
 23. The device of claim 14 wherein the increased thickness is alayer of elastic material having a higher tear strength than the elasticmaterial of the sleeve.
 24. The device of claim 14 including a pluralityof suture holes extending through the sleeve and wherein the increasedthickness is a layer of elastic material having a higher tear strengththan the elastic material of the sleeve and about each of the sutureholes.
 25. The device of claim 24 wherein the layer of elastic materialforms a continuous band about the sleeve.
 26. A constriction device thatconstricts body tissue, the device comprising: sleeve means formed ofelastic material including at least one opened end for constricting bodytissue received therein; suture hole means for receiving a suture tomaintain the sleeve means on the body tissue; and suture holereinforcing means about the suture hole means for reinforcing the suturehole means.
 27. The device of claim 26 wherein the reinforcing meanscomprises an increased thickness of the elastic material about thesuture hole means.
 28. The device of claim 27 wherein the deviceincludes a plurality of suture holes and wherein the reinforcing meanscomprises an increased thickness of the elastic material about each ofthe suture holes.
 29. The device of claim 28 wherein the suture holesare distributed about the sleeve.
 30. The device of claim 28 wherein thesuture holes are distributed about the sleeve near to the at least oneopened end.
 31. The device of claim 28 wherein the increased thicknessof the elastic material forms a band circumscribing the sleeve means andwherein the suture holes extend through the band.
 32. The device ofclaim 31 wherein the band is near to the at least one opened end. 33.The device of claim 26 wherein the suture holes include taperedcross-sections that guide a suture needle into the suture holes.
 34. Thedevice of claim 27 wherein the sleeve means has an inner surface andwherein the increased thickness extends from the inner surface of thesleeve means.
 35. The device of claim 27 wherein the sleeve means has anouter surface and wherein the increased thickness extends from the outersurface of the sleeve means.
 36. The device of claim 26 wherein thereinforcing means is a layer of elastic material having a higher tearstrength than the elastic material of the sleeve means.
 37. The deviceof claim 26 including a plurality of suture holes extending through thesleeve means and wherein the reinforcing means is a layer of elasticmaterial having a higher tear strength than the elastic material of thesleeve and about each of the suture holes.
 38. The device of claim 37wherein the layer of elastic material forms a continuous band about thesleeve means.